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WithdrawnNo phase

Knee Osteoarthritis Outcome Measures in Arthritic Patients With Osteoporosis

Key facts

Who runs it
Edward Fox
Where
Hershey, United StatesSee the site
Trial code
Status
Withdrawn
Started
1 Jan 2020
Ended
31 Dec 2024
Type of study
Observational, 2 groups
Record updated
24 October 2019
Why it stopped
never started

Who can take part

Age
40 years to 80 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • Age: 40-80 years (inclusive)
  • Gender: male or female (non-pregnant)
  • Fluent in written and spoken English
  • Patients capable of giving informed consent
  • Primary diagnosis of osteoporosis that will be treated with either Forteo® to induce bone anabolism or Prolia® by the study investigator as part of patient's standard of care treatment
  • Symptomatic, medial compartment knee OA with a Kellgren-Lawrence (K-L) score between II-III (documented in the medical record by previously collected knee series radiography). Radiographs to be performed within past two years

Who cannot take part

  • Depression (currently taking home medication)
  • Use of immunosuppressants, chemotherapy, or radiotherapy
  • Cognitive impairment
  • History of hyperparathyroidism, hypercalcemia, current/recent renal stones, or malignancy
  • History of inflammatory disease (colitis, rheumatoid arthritis, psoriasis, lupus, scleroderma, spondylitis)
  • Age < 40 or >80 years
  • Pregnancy
  • Non-English speaking persons
  • BMI, angular deformity and K-L score of the contralateral knee (if the OA is bilateral) will be noted as covariates

Where in United States

  • Penn State Milton S. Hershey Medical CenterHershey, United States

About the trial

What the trial wants to find out

The purpose of this study is to generate proof of concept human data by evaluating osteoarthritis outcome measures in arthritic patients that are prescribed Forteo® as the standard of care to treat their primary diagnosis of osteoporosis.

The 2 groups in the trial

  • Forteo

    teriparatide 20-microgram once daily available in a 2.4-mL delivery device for subcutaneous injection by the patient

  • Prolia

    denosumab 60 mg administered as a single subcutaneous injection every 6 months by the health care provider

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Pilot Study to Evaluate Knee Osteoarthritis Outcome Measures in Arthritic Patients Prescribed Forteo or Prolia for Osteoporosis
Record updated
24 October 2019